Kornimate/medical-research-clean huggingface dataset:
a study of patients who received inotuzumab ozogamicin for b-cell all (acute lymphoblastic leukemia) that occurred again after the last treatment

Conditions: Adult Relapsed/Refractory B Cell Acute Lymphoblastic Leukemia

Summary: the purpose of the study was to understand the effectiveness and safety of the study medicine called inotuzumab ozogamicin (ino) in patients with b-cell all in whom the disease occurred again after the last treatment. this retrospective study enroll adult patients who: * were cd22 positive (a molecule in the body that stops the over activity of the immune system) * received only ino for the treatment of b-cell all that occurred again after the last treatment * were philadelphia chromosome positive (which occurs because of changes in genes) * failed treatment with at least one tyrosine kinase inhibitor (type of medicine that blocks the action of enzymes called tyrosine kinases which takes care of many cell functions, such as cell growth and division). the patient data except their personal details are collected from a hospital based electronic medical record in india. in this study the effectiveness and safety of ino will be studied after it was released to the market. to do that, the study aims to gather details of b-cell all patients from 7 -10 hospitals across india: * in whom the disease occurred again * or those who never showed any improvement to earlier treatments * now being treated with ino alone around 55 patients who have taken ino are likely to be enrolled in the study. then by using a statistical model and with all the information gathered, the safety and effectiveness of ino will be decided.


Eligibility criteria:
inclusion criteria: * patients aged ≥18 years old at the initiation of ino treatment * patients with relapsed/refractory b-cell all * patients who initiated ino monotherapy between feb'2017 and feb'2022 and are cd22 positive * ph+ patients who have failed treatment with at least 1 tki exclusion criteria: * patient not completing at least 1 cycle of ino therapy • patient on ino in combination with chemotherapy

Keywords: relapsed all refractory all adult relapsed/refractory all adult all relapsed b cell all refractory b cell all relapsed acute lymphoblastic leukemia refractory acute lymphoblastic leukemia
strict igf-1 control in acromegaly

Conditions: Acromegaly

Summary: acromegaly is a rare, chronic, and debilitating disease, usually caused by a benign tumor on the pituitary gland, which leads to excessive production of growth hormone (gh). gh excess in turn causes overproduction of another hormone called insulin-like growth factor-1 (igf-1). igf-1 levels are currently the most widely accepted measure of disease activity. in canada, medical therapy with a type of medicine called "somatostatin analogues" (ssa), such as octreotide and lanreotide, is recommended for treatment of acromegaly. however, studies have shown that a significant number of patients who take ssa medications alone remain with elevated levels of igf-1 in their blood. another medication that is used to treat acromegaly is pegvisomant (pegv), and the investigators plan to study whether strict control of igf-1, by adding or optimizing the use of pegv, results in a significant health benefits to patients who still have modestly high levels of igf-1 in their blood.


Eligibility criteria:
inclusion criteria: * adult patients (at least 18 years old) with confirmed acromegaly whose igf-i levels are persistently but modestly (1.0 uln \< \[igf-1 serum level\] \< 1.5 uln) elevated following medical therapy such as ssa, pegv, cabergoline alone or in combination. exclusion criteria: 1. progressive or recent visual field loss or optic chiasmal compression, or pituitary tumors within 2mm from the chiasm. patients whose visual field loss, optic chiasmal compression or pituitary tumor has been stable for at least a year will be eligible. 2. cranial nerve palsies or intracranial hypertension requiring tumour decompression surgery 3. clinically significant hepatic disease and/or elevated liver enzymes (alt, ast \> 3 x uln) 4. patients who have received pituitary surgery within one year prior to screening visit 5. patients who have received radiation therapy within one year prior to screening visit 6. history of hypersensitivity to any components of pegvisomant 7. inability to fully comprehend the nature of the study or cooperate with study procedures 8. pregnant / lactating women and subjects refusing to use adequate contraception to prevent pregnancy during the study. 9. subjects unwilling or unable to self-administer medication on a daily basis 10. known or suspected alcohol / drug abuse 11. severe acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with trial participation.
enterotomy closure and minimally invasive gastrectomy

Conditions: Gastric Cancer

Summary: all consecutive patients from january 2009 to december 2019 who underwent minimally invasive partial gastrectomy for gastric cancer at thirteen high volume institutions will be retrospective analysed to assess the better way to fashion a handsewn intracorporeal enterotomy closure after a stapled anastomosis.

different ways to fashion intracorporeal anstomoses will be investigated: robotic vs laparoscopic approach; laparoscopic hd vs 3d vs 4k technologies; single layer vs double layer enterotomy closure. additionally double layer enterotomies will be analysed layer by layer, comparing running vs interrupted suture, presence vs absence of deep corner suture and type of suture thread (barbed, braided, non braided suture)

Eligibility criteria:
inclusion criteria: * age \> 18 years * laparoscopic or robotic partial gastrectomy for gastric cancer * roux en y or billroth ii reconstruction exclusion criteria: * age \< 18 years * open gastrectomy * total gastrectomy * billroth i reconstruction

Keywords: intracorporeal gastrectomy enterotomy closure
a study of sc-007 in subjects with advanced cancer

Conditions: Colorectal Cancer (CRC); Gastric Cancer

Summary: this is a multicenter, open-label, phase 1 study in participants with colorectal cancer (crc) or gastric cancer to study the safety and tolerability of sc-007 and consists of part a (dose regimen finding) in participants with crc followed by part a in participants with gastric cancer. part b (dose expansion) will enroll participants into separate disease specific cohorts of crc or gastric cancer.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed advanced metastatic or unresectable advanced colorectal cancer (crc) or gastric cancer that is relapsed, refractory, or progressive after: * crc: at least 2 prior systemic regimens in the metastatic setting, and as appropriate in patients whose tumors are microsatellite instability-high (msi-h), pembrolizumab as well. * gastric cancer (including gastric and egj cancers): at least 2 prior systemic regimens in adjuvant, advanced, or metastatic setting and, as appropriate, a human epidermal growth factor receptor 2 (her2) targeted agent. * eastern cooperative oncology group (ecog) performance status of 0 or 1 * adequate hematologic, hepatic, and renal function. exclusion criteria: * any significant medical condition that, in the opinion of the investigator or sponsor, may place the participant at undue risk from the study. * has electrocardiogram (ecg) abnormalities that make qt interval corrected (qtc) evaluation difficult. * prior exposure to a pyrrolobenzodiazepine or indolinobenzodiazepine based drug.

Keywords: cancer advanced cancer esophagogastric junction (egj) cancers maximum tolerated dose (mtd) maximum tolerated dose pharmacokinetics
ventriculo-arterial coupling modification evaluated by pram during tavi procedure

Conditions: Aortic Valve Stenosis; Ventricular Dysfunction, Left

Summary: calcified aortic stenosis is the most frequent valvulopathy in europe and north america. aortic stenosis is an obstacle to the ejection of blood from the left ventricle to the aorta and leads to morphological changes in the left ventricle and hemodynamic modifications. intrinsic ventricular performance can be characterized using three parameters: * ventricular elastance (ees for end systolic elastance) which represents the index of ventricular contractility independently of the load. * arterial elastance (ea for arterial elastance) which represents the post-load * the ventriculo-arterial coupling index (ees / ea) which represents energy efficiency. for patients with high surgical risk (euroscore ii\> 6), tavi (transcatheter aortic valve implantation) is recommended for aortic valve replacement. many complications may occur after tavi (haemorrhagic, embolic, renal, myocardial ischemia). post-tavi complications may also be cardiac decompensation of the underlying cardiac disease to cardiogenic shock. however, literature on left ventricular performance after aortic valvular replacement is poor because of the difficulty and invasiveness of the analysis involved. cardiac energy analysis plays an additional role in understanding the clinical patients conditions. on this point, cardiac energy modifications, based on ventriculo-arterial coupling, could be indicators of cardiac function. two methods (ultrasound and pulse contour) are used to understand and explore the ventriculo-arterial coupling, preload, postload, contractility and hemodynamic changes interactions. echocardiography allows the ees / ea and sw / pva (stoke work/ pressure-volume area) ratios mesurements. pram (pressure recording analytical method) through the mostcare® monitor, gives common hemodynamic parameters and more specific parameters such as arterial elastance (ea) cardiac cycle efficiency (cce), dp / dt. cardiac cycle efficiency (cce) is an exclusive variable that describes the hemodynamic performance in terms of energy expenditure in the patient being followed. tavi procedure is an acute model of ventriculo-arterial coupling modification by treatment of the ventricular ejection obstacle. the pram method evaluates the ventriculo-arterial coupling. the aim of our study is to evaluate by pram the changes in cardiac energy variables before and after aortic valve replacement by tavi


Eligibility criteria:
inclusion criteria: * age \>18 years * elective tavi intervention with femoral access * consent exclusion criteria: * permanent arrhythmias * pacemaker dependency * moderate to severe mitral or tricuspid valve regurgitation * intracardiac shunt

Keywords: transcatheter aortic valve replacement pressure recording analytical method ventriculo-arterial coupling monitoring hemodynamic
in-situ cytokines expression in the cns in amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis

Summary: the investigators aim at exploring the differential/topographical in-situ expression of cytokines in the central nervous system (cns) of patients who died with amyotrophic lateral sclerosis (als), using archived histopathology slides and residual paraffin blocks from autopsied cases. previous studies from the investigators and other groups showed that inflammatory cytokines are implicated in several neurological affections, particularly neurodegenerative conditions. however, in-situ cytokine expression has never been studied so far in als. the investigators wanted to see if these neuro-mediators are involved in the neuromolecular chain/cascade underlying als.


Eligibility criteria:
inclusion criteria: * patients who died with amyotrophic lateral sclerosis, having been autopsied. exclusion criteria: * n/a

Keywords: amyotrophic lateral sclerosis (als) cytokines neuropathology
hepatitis c treatment in probation and parole office

Conditions: Hepatitis C; HCV

Summary: this prospective cohort study compares aims to determine the efficacy and effectiveness of telemedicine-supported on-site linkage to care and treatment in a community probation and parole office (p\&p office) setting and compare the results with a historic control with referral to care. research participants will be followed in the p\&p office when they report to their officer during regularly scheduled appointments. participants will receive treatment without having to travel to a specialist's office. the telemedicine visit will include a consultation with an experienced hcv provider such as a hepatologist or an advanced practice provider and a specialty pharmacist who will educate about and monitor hcv treatment. the uk specialty pharmacy will be available to participants and the hcv management team through a 24-hour support line. participants will be treated per hcv guidelines and insurance preference.


Eligibility criteria:
inclusion criteria: * clients who will be supervised in the probation and parole office for at least 5 months * history of hepatitis c * able to obtain health insurance * capacity to provide written, informed consent * life expectancy \>1 year exclusion criteria: * negative hcv rna * pregnant or breast-feeding * hiv or hbv co-infection * liver cirrhosis with child-turcotte-pugh score 6 or greater at baseline lab work * subjects with impaired capacity to provide informed consent

Keywords: parole probation telemedicine
cp1150 sound processor speech perception compared with the next generation of signal processing technology

Conditions: Hearing Impairment, Sensorineural

Summary: this clinical study aims to investigate speech performance in quiet with an ote sound processor with modified firmware compared with the commercially available cp1150. the study also investigates cp1110 and cp1150 with forward focus.

this study will build on the evidence previously collected on ote and bte sound processors and will support the design goals for access to the same sound processing algorithms across future ote and bte variants, including evidence required on the automation of ff and future implant compatibility.

Eligibility criteria:
inclusion criteria: 1. aged 18 years or older 2. post lingually deafened 3. implanted with the ci600 series, ci500 series or freedom series 4. at least 6 months experience with a cochlear implant. 5. at least 3 months experience with a cp910/920, cp950, cp1150, or cp1000 sound processor 6. map total stimulation rate of 7.2khz or greater 7. able to score 30% or more with ci alone on a monosyllabic words in quiet test 8. willingness to participate in and to comply with all requirements of the protocol 9. fluent speaker in english as determined by the investigator 10. willing and able to provide written informed consent exclusion criteria: 1. additional disabilities that would prevent participation in evaluations. 2. implant location that would result in undesirable hearing performance or discomfort with an off-the-ear sound processor, as determined by the investigator. 3. unable or unwilling to comply with the requirements of the clinical investigation, as determined by the investigator. 4. investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. 5. cochlear employees or employees of contract research organisations or contractors engaged by cochlear for the purposes of this investigation. 6. currently participating or participated in another interventional clinical study/trial in the past 30 days unless (if less than 30 days) the prior investigation was cochlear sponsored and determined by the investigator to not impact clinical findings of this investigation. 7. implanted with other active implantable medical devices (e.g. pacemaker, defibrillator).
long-term multi-center evaluation of e-poly and regenerex

Conditions: Osteoarthritis of Hip; Traumatic Arthritis of Hip

Summary: there are two distinct aims of this study: 1. this prospective study is designed to document the long-term (10-year) radiographic and clinical outcomes of a new type of highly cross-linked polyethylene liner which contains vitamin e as an anti-oxidant, (e-poly), in a group of primary total hip arthroplasty subjects. the clinical outcome of e-poly will be compared to a group of subjects receiving arcom xl polyethylene. 2. this study is also designed to document the long-term (10-year) radiographic and clinical outcomes of a new cementless acetabular component having a titanium porous surface (regenerex). the clinical outcome of this new fda cleared device will be compared a group of subjects receiving an acetabular component having a plasma sprayed surface.


Eligibility criteria:
inclusion criteria: * subjects requiring primary total hip replacement * subjects with diagnosis of osteoarthritis or traumatic arthritis * subjects who demonstrate the ability to return for follow-up for the next 10 years exclusion criteria: * subjects with limited life span * subjects with difficulty in comprehending study protocol for any reason. * subjects with inflammatory disease, previous infection or those requiring revision hip surgery. * subjects with avascular necrosis * subjects whose bony structures are so small that a femoral head less than 32mm in diameter must be used. * subjects whose bony structure deviates substantially from the general norm sufficiently to require non-standard techniques and non-standard implants. specific examples of these are total dislocation of the hip, severe coxa vera deformity, severe forms of multiple epiphyseal dysplasia * subjects with complex disease entities which significantly increase the risks of the surgery such as any major platelet abnormality, hematological disorder, positive for hiv or any other major medical complication which substantially reduces longevity. * female subjects that are pregnant or who may suspect they are pregnant or who plan to become pregnant while participating in this study.

Keywords: clinical outcomes radiographic outcomes total hip arthroplasty survivorship
effects of lumbar traction on the straight leg raise test and pain

Conditions: Prolapsed Intervertebral Disc

Summary: disc prolapse causes impairment of function by nerve root compression compelling the patient to seek medical advice for low backache. traction is one of the physical modalities frequently used for the treatment of lumbar disc herniations. so the purpose of the study is to determine the effect of one-fifth, one-half, and one-third of body weight traction on the straight leg raise test and pain.

a total of 45 patients suffering from lumbar pivd and having neurological symptoms will be selected for the study. lumbar pivd will be confirmed from mri. participants will be divided into three groups with 15 participants in each group. group a. for one-fifth of body weight traction, group b for one-third of body weight traction, and group c for one-half of body weight traction. slr and pain will be measured before traction and after traction. a goniometer will be used to measure slr and vas will be used to measure pain.

Eligibility criteria:
inclusion criteria: * back pain for less than 3 months * positive unilateral straight leg raise test which includes reports of back and leg pain or paraesthesia below 45-degree hip flexion * at least one additional neurological sign should be present including- (a) diminished achillis/hamstring tendon reflex, tested in the supine position or (b) hyposthesia in any of the l4-s2 dermatome, or (c) muscle weakness in any of the l4-s2 myotome. * mri evidence of l-4-l5 or l5-s1 disc prolapse or both. exclusion criteria: * malignancy, tuberculosis, osteoporosis, osteomyelitis of the vertebral column * cord compression, pregnancy, hypertension, cardiovascular disease, joint hyper mobility * subjects who could not tolerate the traction force secondary to being in an acute stage of back pain. * subjects who have taken previous physiotherapy treatment in the last three months for back pain.

Keywords: mechanical traction prolapsed intervertebral disc straight leg raise test pain
study of rmc-6236 in patients with advanced solid tumors harboring specific mutations in ras

Conditions: Non-small Cell Lung Cancer (NSCLC); Colorectal Cancer (CRC); Pancreatic Ductal Adenocarcinoma (PDAC); Advanced Solid Tumors

Summary: evaluate the safety and tolerability of rmc-6236 in adults with specific ras mutant advanced solid tumors.

this is a phase 1/1b, multicenter open-label study to evaluate the safety, tolerability, pharmacokinetics (pk), and clinical activity of escalating doses of rmc-6236 in adult patients with advanced solid tumors harboring specific ras mutations, and to determine the maximum tolerated dose (mtd) and/or recommended phase 2 dose \[rp2d\] within investigated patient population groups. rmc-6236 is a potent, orally bioavailable ras-multi(on) inhibitor, selective for the active ras(on) form of both wild type and mutant variants of the canonical ras isoforms (hras, nras, and kras).

Eligibility criteria:
inclusion criteria: * histologically confirmed advanced solid tumor with specific kras g12 mutations (dose escalation) or ras mutations (dose optimization/expansion) identified through deoxyribonucleic acid (dna) sequencing. pdac with wild-type ras (expansion). * received prior standard therapy appropriate for tumor type and stage * have eastern cooperative oncology group (ecog) performance status of 0 or 1 * adequate organ function exclusion criteria: * primary central nervous system (cns) tumors * active, untreated brain metastases * known or suspected impairment of gastrointestinal function that may prohibit ability to swallow or absorb an oral medication * history of any other unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a participant, impact their expected survival through the end of the study participation, and/or impact their ability to comply with the protocol prior/concomitant therapy other inclusion/exclusion criteria may apply.

Keywords: kras non-small cell lung cancer lung cancer colorectal cancer colon cancer metastatic cancer pancreatic cancer pancreatic ductal adenocarcinoma nsclc crc pdac pancreatic neoplasms carcinoma, pancreatic ductal colorectal neoplasms colonic neoplasms intestinal neoplasms gastrointestinal neoplasms lung neoplasms carcinoma, non-small-cell lung neoplastic processes thoracic neoplasms antineoplastic agents melanoma gynecological cancers ras
search for bio diagnostic and prognostic markers in adult vascularitis

Conditions: Vasculitis

Summary: to date, there are no reliable diagnostic blood markers of adult vasculitis. to date, the diagnosis of vasculitis is based on invasive procedure, biopsy of affected tissues potentially at risk of complication . in addition, there are no reliable biomarkers to predict the evolution of vasculitis (relapse, refractory form ...) necessary for the management of patients (type of treatment, duration ..) prospective study, monocentric (chu de tours), non-interventional, aimed at finding diagnostic and prognostic biomarkers (both metabolomic and immunologic) in adult vasculitis patients.

specimen will be collected at diagnosis, month 1, month 3, and month12 and at the time of a possible relapse. 14 ml of additional blood during a blood puncture made for routine care will be collected at each visit as well as clinical data.

Eligibility criteria:
inclusion criteria: * age \> 16 years * active vasculitis, new diagnosis or relapse * iga vasculitis * anca vasculitis * giant cell arteritis exclusion criteria: * person who has objected to the processing of data * pregnant woman * patient positive for hiv, hbv, hcv * treatment in the previous month with corticosteroids, immunosuppressive drugs or biotherapy. * patient unable to understand the information leaflet * adult under guardianship or curatorship

Keywords: biomarkers diagnosis prognosis